Industry project aims to cut animal testing of excipients

By Anna Lewcock

- Last updated on GMT

Related tags Animal testing Pharmaceutical industry

10 major pharmaceutical companies are taking part in an
international data-sharing initiative to drive down the need for
animal testing.

The firms, all significant players in the pharmaceutical industry according to the company co-ordinating the scheme, will share data on the effects of pharmaceutical excipients so as to avoid duplication of experiments and unnecessary tests on animals.

The recently introduced European chemical reforms (Registration, Evaluation and Authorisation of Chemicals - REACH), which require pharma companies to formally verify the safety of the chemicals they use, will no doubt call for increased collaboration of this kind in a bid to reduce multiple repetition of experiments by different companies.

The software for the new database has been developed by UK-based charity Lhasa, which will also be responsible for administrating and managing the project.

The database will comprise both public and proprietary data, enabling companies taking part in the scheme access to research carried out by other member firms which could help them streamline their own research programmes as well as reducing the need for animal testing.

Data collected by the companies from their experiments will be collated and then inputted by Lhasa's resident scientists into the database, which is powered by the company's Vitic software.

Vitic, the company's newest software, is primarily a toxicity database and management system that is continually updated and, according to the company, offers a fast and efficient way of accessing chemical toxicity information.

In order to take part in the data-sharing programme, companies must buy a software license which will then allow them access to the combined data supplied by other member companies.

The information is currently restricted so that only members of the specific scheme can access it, though Lhasa may eventually make the data available to all member companies.

The 3Rs - the replacement, refinement and reduction of animals in research - is an initiative that has been garnering increased attention over the past few years, with companies more conscious of the need to reduce animal testing and increased consumer awareness of the use of animals in pharmaceutical research.

In 2004, the establishment of the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) by the UK government reflected this increased focus on adopting animal alternatives.

According to NC3Rs, animal use by the pharmaceutical industry has decreased over recent years, as the sector has invested in high-technology alternatives such as robotics and in vitro systems.

However, it is more difficult to replace animals at more advanced stages of drug screening, with toxicity, vaccine and other forms of safety testing still requiring animal models to illustrate the impact of new drugs on a whole body system.

Lhasa's new data-sharing scheme has been formulated with support from the Royal Society for the Prevention of Cruelty to Animals (RSPCA) and the Fund for the Replacement of Animals in Medical Experiments (FRAME).

Although the company was unable to disclose specific companies involved in the scheme, FRAME lists several major pharmas as supporters of the charity and its work, including AstraZeneca UK, GlaxoSmithKline, Johnson & Johnson, Sanofi-Aventis and Novo Nordisk.

A spokesperson from Sanofi-Aventis, although unable to confirm the company's participation in the data-sharing scheme, told In-PharmaTechnologist: "FRAME's objectives in this area seem aligned to ours and I can confirm that for Sanofi-Aventis clinical research…animals are used only in instances where validated alternatives are not available."

Representatives from the other pharmaceutical companies were not available for comment at the time of publication.

The new database also offers companies involved an option for reacting to the recently introduced European chemical reform, REACH (Registration, Evaluation and Authorisation of Chemicals).

The legislation, passed in December last year, will force companies to establish the safety of thousands of chemical substances, and requires data-sharing between companies registering the same chemicals in order to avoid duplication of animal experiments.

"The introduction of REACH is expected to increase the need for data-sharing within the chemistry and life sciences sectors," said Dr Philip Judson, Lhasa business development advisor.

"This project will be the first, publicly visible example of the sharing of proprietary data, undertaken voluntarily by major private organisations."

Lhasa is a not-for-profit organisation offering several information software packages for the drug discovery industry, including 'Derek' for predicting toxicity, 'Meteor' for predicting metabolic fate, as well as the 'Vitic' toxicological database and management system.

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